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O*NET-SOC 11-9199.01

Regulatory Affairs Managers

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

From O*NET 30.3

Tasks

From O*NET 30.3, by importance, as O*NET OnLine lists them

Free · O*NET 30.3
  1. Develop regulatory strategies and implementation plans for the preparation and submission of new products.Core18026
  2. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.Core18037
  3. Direct the preparation and submission of regulatory agency applications, reports, or correspondence.Core18022
  4. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.Core18029
  5. Provide responses to regulatory agencies regarding product information or issues.Core18035
  6. Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.Core18036
  7. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.Core18024
  8. Manage activities such as audits, regulatory agency inspections, or product recalls.Core18031
  9. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.Core18025
  10. Maintain current knowledge of relevant regulations, including proposed and final rules.Core18030
  11. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.Core18023
  12. Direct documentation efforts to ensure compliance with domestic and international regulations and standards.Core21087
  13. Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.Core18038
  14. Participate in the development or implementation of clinical trial protocols.Core18034
  15. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.Core18028
  16. Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.Core18043
  17. Establish regulatory priorities or budgets and allocate resources and workloads.Core18027
  18. Train staff in regulatory policies or procedures.Core18039
  19. Develop and maintain standard operating procedures or local working practices.Core18042
  20. Contribute to the development or implementation of business unit strategic and operating plans.Core18040
  21. Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.Core19531
  22. Coordinate internal discoveries and depositions with legal department staff.Core18041
  23. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.Core18032
  24. Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.Core19529
  25. Monitor regulatory affairs trends related to environmental issues.Core19532
  26. Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.Core19530
  27. Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.Supplemental18044

Technology Skills

From O*NET 30.3, 67 examples in 20 categories, 14 Hot Technology

Free · O*NET 30.3

Document management software

  • Adlib Express
  • Adobe AcrobatHot Technology
  • Axway eSubmissions
  • Datafarm a-Pulse
  • Datafarm eCTDGatekeeper
  • Datafarm eCTDViewer
  • Datafarm S-Cubed
  • DoubleBridge ROSETTA Phoenix eCTD Viewer
  • DoubleBridge ROSETTA Pyramid
  • DoubleBridge ROSETTA Sceptre
  • DoubleBridge ROSETTA Scribe
  • Electronic common technical document eCTD software
  • Electronic common technical document eCTD validating software
  • Electronic common technical document eCTD viewing software
  • Electronic document management system EDMS
  • Enterprise content management ECM software
  • Extedo DOCvalidator
  • Extedo eCTDmanager Suite
  • Extedo PLmanager
  • GlobalSubmit REVIEW
  • GlobalSubmit VALIDATE
  • Image Solutions eCTDXpress
  • Image Solutions ISIPublisher
  • Lorenz DocuBridge
  • Lorenz eValidator
  • Lorenz labelBridge
  • MedXView eCTDauditor
  • Microsoft SharePointHot Technology
  • Octagon StartingPoint
  • Octagon ViewPoint eCTD Complete
  • Take Solutions PharmaReady Document Management System
  • Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD
  • Virtify eCTD

Analytical or scientific software

  • Analyse-it
  • Statistical analysis software

Compliance software

  • Aris Global Register
  • MediRegs E-dition Compliance Monitor
  • MediRegs Pharmaceutical Regulation Suite
  • MediRegs Regulation and Reimbursement Suite
  • MediRegs Risk Assessment Manager
  • Pilgrim Regulatory Submission
  • Samarind RMS
  • SAP EHS Management
  • Thomson Reuters Liquent InSight Suite

Data base user interface and query software

  • Database software
  • Microsoft AccessHot Technology
  • Structured query language SQLHot Technology

Information retrieval or search software

  • Dialog DialogLink

Desktop publishing software

  • Document publishing software

Electronic mail software

  • IBM Notes
  • Microsoft OutlookHot TechnologyIn Demand

Development environment software

  • Integrated development environment IDE software
  • Software development tools

Risk management data and analysis software

  • MasterControl software
  • Risk management software

Spreadsheet software

  • Microsoft ExcelHot TechnologyIn Demand

Office suite software

  • Microsoft Office softwareHot TechnologyIn Demand

Presentation software

  • Microsoft PowerPointHot TechnologyIn Demand

Project management software

  • Microsoft ProjectHot Technology
  • Total quality management TQM software

Process mapping and design software

  • Microsoft VisioHot Technology

Operating system software

  • Microsoft WindowsHot Technology

Word processing software

  • Microsoft WordHot Technology

Enterprise resource planning ERP software

  • SAP softwareHot Technology

Business intelligence and data analysis software

  • TableauHot Technology

Internet browser software

  • Web browser software

Enterprise application integration software

  • XML authoring software

Detailed Work Activities

From O*NET 30.3, under their work activities; open one for the AI skills Workforce Automation maps to it

Free · O*NET 30.3

Getting Information

  • Evaluate environmental impact of operational or development activities.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Monitoring Processes, Materials, or Surroundings

  • Monitor organizational procedures to ensure proper functioning.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Monitor external affairs or events affecting business operations.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Monitor organizational compliance with regulations.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Judging the Qualities of Objects, Services, or People

  • Evaluate potential of products, technologies, or resources.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Evaluating Information to Determine Compliance with Standards

  • Examine marketing materials to ensure compliance with policies or regulations.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Review documents or materials for compliance with policies or regulations.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Making Decisions and Solving Problems

  • Implement organizational process or policy changes.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Thinking Creatively

  • Develop organizational goals or objectives.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Updating and Using Relevant Knowledge

  • Maintain knowledge of current developments in area of expertise.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Developing Objectives and Strategies

  • Develop organizational policies or programs.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Develop operating strategies, plans, or procedures.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Develop organizational methods or procedures.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Documenting/Recording Information

  • Prepare reports related to compliance matters.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Maintain regulatory or compliance documentation.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Interpreting the Meaning of Information for Others

  • Communicate organizational policies and procedures.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Communicating with Supervisors, Peers, or Subordinates

  • Confer with organizational members to accomplish work activities.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Establishing and Maintaining Interpersonal Relationships

  • Establish interpersonal business relationships to facilitate work activities.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Coordinating the Work and Activities of Others

  • Coordinate with external parties to exchange information.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Coordinate operational activities with external stakeholders.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Represent the organization in external relations.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Prepare staff schedules or work assignments.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Coordinate regulatory documentation activities.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Manage documentation to ensure organization or accuracy.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Training and Teaching Others

  • Conduct employee training programs.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Guiding, Directing, and Motivating Subordinates

  • Manage control system activities in organizations.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet
  • Prepare operational budgets.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Providing Consultation and Advice to Others

  • Advise others on legal or regulatory compliance matters.
    WFA · Part of the paid plan when accounts open

    WFA (Workforce Automation) analysis: 0 of 0 AI skills mapped to this activity, by automation level

    • No tools yet
    • Not mapped yet

Job Zone

From O*NET 30.3

Free · O*NET 30.3

Job Zone Four: Considerable Preparation Needed

Workforce Automation analysis, not part of the source

WFA coverage: AI skills for this job

WFA · Part of the paid plan when accounts open

Pilot mapping: these skill links come from our seed list and haven’t been reviewed yet. Expect them to change as each one is checked.

DWAs covered by an AI skill0 of 28
Distinct tools0
Level mix
  • No tools yet

Equivalents

NICE work roles, with their DCWF equivalents

Mapped to this job by the ETO-CSET NICE/O*NET crosswalk (2024); roles from NICE Framework Components v2.2.0, DCWF equivalents from DoD DCWF Tool v5.3 (2026-09-25)

Free · NICE Framework Components v2.2.0 and DoD DCWF Tool v5.3 (2026-09-25)

No NICE work role maps to this job.